APO-Paracetamol Codeine

APO-Paracetamol/Codeine 500/30

Contains the active ingredients, paracetamol and codeine phosphate

Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
questions about APO-Paracetamol Codeine. It does
not contain all the information that is known about
APO-Paracetamol Codeine. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is APO-Paracetamol/Codeine 500/30. It contains the active ingredients paracetamol and codeine phosphate.
It is used for the relief of moderate to severe pain when milder painkillers are not effective.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed
this medicine for another reason.

This medicine is available only with a doctor's prescription.

How it works

Paracetamol belongs to a group of medicines called analgesics (painkillers). Analgesics are used to block pain. It is also
an antipyretic which means that it helps reduce your body temperature if you have a fever.

Codeine phosphate also belongs to the group of medicines called analgesics and it acts by blocking pain and your emotional
response to pain.

Use in children

This medicine is not suitable for use in children under 7 years of age.

Before you take this medicine

When you must not take it

Do not take this medicine if:

You have or have had any of the following:

Problems breathing due to asthma, or lung disease such as bronchitis or emphysema

You are suffering from diarrhoea caused by poisoning or antibiotics.

If you regularly drink excessive amounts of alcohol

You are hypersensitive to, or have had an allergic reaction to:

Paracetamol

Codeine

Morphine

Oxycodone

any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the
face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.

If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately
or go to the Accident and Emergency department at the nearest hospital.

The expiry date (EXP) printed on the pack has passed.

The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1.You have allergies to:

any other medicines

any other substances, such as foods, preservatives or dyes.

2.You have or have had any medical conditions, especially the following:

liver disease or hepatitis, or you are taking other medicines which affect the liver

kidney disease or difficulty urinating

inflammatory bowel disease or other gastrointestinal problems

lung disease or problems breathing

convulsions or epilepsy

CNS depression (decreased alertness or decreased consciousness due to any cause)

Addison's disease (low activity of the adrenal gland)

An underactive thyroid gland

Recent head injury or brain tumour or increased pressure within the head (intracranial pressure)

Recent gastrointestinal tract or urinary tract surgery

Prostate problems

Heavy alcohol or drug use

3.You are currently pregnant or you plan to become pregnant.

Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.

4.You are currently breastfeeding or you plan to breast-feed.

Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.

Paracetamol and codeine pass into breast milk so it is not recommended for nursing mothers. If this is taken by nursing mothers
it may make them drowsy and not as able to look after their babies, and it may also make the babies very sleepy and unable
to feed and breathe properly. If this happens you should seek medical advice immediately.

5.You are elderly.

Elderly patients are more likely to have less effective kidneys or liver. This may increase the risk of side effects. The
codeine in these tablets may also make you feel drowsy. You should discuss how many tablets to take with your doctor.

6.You are planning to have surgery or an anaesthetic.

7.You are currently receiving or are planning to receive dental treatment.

8.You are taking or are planning to take any other medicines.

This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Do not take these tablets with other medicines containing paracetamol or codeine, unless your doctor says you can.

Some medicines may interact with APO-Paracetamol/Codeine 500/30. These include:

barbiturates

medication for epilepsy

salicylates or NSAIDs, medicines used for pain relief and arthritis

medicines to help you sleep, or relieve anxiety

monoamine oxidase inhibitors (medicines for treating depression or Parkinson's Disease) taken within the last 10 days

medicines to reduce blood pressure

medicines to treat diarrhoea

metoclopramide, used to treat nausea and vomiting

medicines used during operations (anaesthetics, muscle relaxants

medicines used to prevent blood clots (anticoagulants)

chloramphenicol or rifampicin, used for treating bacterial infections

zidovudine, used for treating viral infections

cholestyramine, used for lowering cholesterol or treating certain types of diarrhoea

other strong painkillers called opioids

medicines called anticholinergics, used for stomach problems (ulcers, cramps, diarrhoea).

If you are taking any of these you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with APO-Paracetamol/Codeine 500/30.

Drinking alcohol with this medicine may increase the toxic effects of alcohol or the side effects of APO-Paracetamol/Codeine
500/30, and should be avoided.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this
leaflet.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are
taking any other medicines.

The recommended doses for APO-Paracetamol/Codeine 500/30 tablets are:

Adults and children over 12 years:

1 to 2 tablets every four hours as necessary

Do not take more than eight tablets in one day.

Children 7 to 12 years:

Half a tablet every four hours as necessary.

Children must not take more than three tablets in one day.

APO-Paracetamol/Codeine 500/30 is not suitable for children under 7 years of age.

How to take it

Swallow the medicine with water.

If the dose is half a tablet, there is a break line on the tablet to help you divide it.

When to take it

It does not matter if you take it before, with or after food.

How long to take it for

Adults and children over 12 years:

Take this medicine for no longer than a few days at a time unless your doctor advises otherwise.

Children 7-12 years:

Do not take for longer than 48 hours at a time unless your doctor advises otherwise.

If pain persists, see your doctor.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next dose at the usual time. Otherwise, take
it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for missed doses.

This may increase the chance of you experiencing side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons
Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at
your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you experience any of the following, stop taking your medicine and contact your doctor immediately or go to the Accident
and Emergency department at your nearest hospital.

These are very serious side effects and you may need urgent medical attention or hospitalisation. These side effects are usually
very rare:

symptoms of an allergic reaction, e.g. shortness of breath, wheezing or difficulty breathing; swelling of the face, lips,
tongue, throat or other parts of the body; muscle pain or tenderness or joint pain or rash, itching or hives on the skin.

problems breathing which are not due to allergy.

Other side effects not listed above may occur in some patients.

Allergic reactions

If you think you are having an allergic reaction to Paracetamol/Codeine, do not take any more of this medicine and tell your
doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

cough, shortness of breath, wheezing or difficulty breathing

swelling of the face, lips, tongue, throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 30°C.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in
the car. Heat and dampness can destroy some medicines.

Keep this medicine where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the
remaining medicine safely.

Product description

What APO- Paracetamol/Codeine 500/30 looks like

White bevelled edge capsule-shaped tablets, plain on one face with a single break bar on the other side.

Blister packs of 20 tablets.

* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains paracetamol 500mg and codeine phosphate 30mg as the active ingredient.

It also contains the following inactive ingredients:

wheat starch (contains gluten)

microcrystalline cellulose

purified talc

magnesium stearate

gelatin

This medicine is lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

APO-Paracetamol/Codeine 500/30 (Blisters): AUST R 153124

Sponsor

Aspen Pharma Pty Ltd

34-36 Chandos Street

St Leonards NSW 2065

Distributor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from the registered proprietor, Apotex Inc.

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